GLOBAL UNITE 2100-01-035Recalls & reported problems
Depuy (Ireland) · GLOBAL UNITE IMPLANT HOLDER · Class 1
All models of GLOBAL UNITE (91)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295085188), received between Mar 9, 2022 and Jul 31, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (3 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility3
- Unintended Movement2
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 31, 2024Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement
IT WAS REPORTED THAT THIS WAS A SHOULDER ARTHROPLASTY FOR OSTEONECROSIS OF THE HUMERAL HEAD PERFORMED ON (B)(6) 2024. THE UNITE IMPLANT HOLDER¿S GRIP ON THE IMPLANT WAS WEAK AND LOOSE. IT WAS NOT WEAK THAT THE IMPLANTS FELL OFF. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19879464 ↗MalfunctionApr 28, 2023Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement
ADDITIONAL INFORMATION FROM THE EVENT DESCRIPTION INDICATES THAT THERE WAS A 5 MINUTES SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16835191 ↗MalfunctionSep 19, 2022Break; Break
IT WAS REPORTED THAT THE STEM INSERTION HANDLE LATCH BROKE WHEN ATTACHING IMPLANT. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15445780 ↗MalfunctionMar 9, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE HANDLE WASN'T CONNECTING WITH IMPLANT/TRIAL APPROPRIATELY. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13711500 ↗
Other IMPACTOR devices
- PINNACLE 2217-50-041Depuy (Ireland) · IMPACTOR4,295 reports
- ATTUNE 2544-01-006Depuy (Ireland) · IMPACTOR1 recall2,539 reports
- ATTUNE 2544-01-003Depuy (Ireland) · IMPACTOR1 recall1,498 reports
- ATTUNE 2544-01-017Depuy (Ireland) · IMPACTOR1 recall1,456 reports
- ATTUNE 2544-01-004Depuy (Ireland) · IMPACTOR1 recall875 reports
- DURALOC 2360-71-000Depuy Orthopaedics, Inc. · IMPACTOR716 reports
- SPECIALIST 2581-11-000Depuy (Ireland) · IMPACTOR704 reports
- INHANCE 6205-10-103Depuy (Ireland) · IMPACTOR337 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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